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Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL) (FAD)

Primary Purpose

T-Cell Lymphomas, Chemotherapy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
FAD
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-Cell Lymphomas focused on measuring Peripheral T-cell lymphomas (PTCL), Fludarabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The diagnosis of peripheral T cell lymphoma must established by histological biopsy, and immunochemistry analysis and cytogenetic assessment should be done as well. The patients with peripheral T cell lymphoma (PTCL), PTCL-unspecified type(PTCL-u), angioimmunoblastic lymphoma (AILT) and non-skin type anaplastic large cell lymphoma (ALCL, ALK-).
  2. Aged 18~75.
  3. Good performance status, ECOG score≤2. Estimated survival span >3 months
  4. Previously untreated.
  5. At least 1 assessable disease (maximal diameter >1.0cm, the disease foci located within the irradiated area are excluded) evaluated by CT or MRI, PET is also permitted.
  6. Good compliance and inform consenting

  7. Fit for the following criteria:

    • Absolute neutrophil count (ANC)≥1.5×109/L
    • Platelet（PLT）≥80×109/L
    • Total bilirubin (TBI) ≤upper normal limit (UNL)
    • Serum creatine (Cr) ≤UNL
    • Alanine aminotransferase (ALT) and Aspartate transaminase（AST）≤1.5 UNL

Exclusion Criteria:

  1. Severe cardiac, renal or hepatic incompetence: serum direct bilirubin, indirect bilirubin, ALT, AST and Cr greater than 1.5 UNL; cardiac function greater than grade II. 28 days within the major surgical operation.
  2. Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded)
  3. Severe uncontrolled underlying diseases
  4. Pregnancy or lactation
  5. Autoimmune disease history
  6. Severe infection or metabolic diseases
  7. Known allergic to multiple agents, including sulphanilamide.
  8. Severe peptic ulceration or bleeding, contra-indicative for corticosteroids
  9. Lymphoma involving central nervous system

Sites / Locations

  • Cancer Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

side effects

Secondary Outcome Measures

PFS (progression free survival)
complete remission(CR)

Full Information

First Posted
February 9, 2009
Last Updated
September 14, 2010
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT00840385
Brief Title
Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)
Acronym
FAD
Official Title
Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas (PTCL). 30 patients will be treated into this study.
Detailed Description
Doxorubicin is often used to treat Peripheral T-cell lymphomas (PTCL). However, patients with PTCL have an especially poor outcome with a 5-year overall survival rate of only 26% following treatment with standard doxorubicin containing regimens. There is general agreement that results with conventional chemotherapy are so poor in patients with most PTCL that new approaches are warranted.The nucleoside analogs are Fludarabine being combined with other agents in PTCL (excluding ALK positive ALCL and primary cutaneous ALCL) is reported by others.We conduct a II stage clinical trials to evaluate the efficacy of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with in Newly Diagnosed PTCL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-Cell Lymphomas, Chemotherapy
Keywords
Peripheral T-cell lymphomas (PTCL), Fludarabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FAD
Other Intervention Name(s)
Fludarabine phosphate, oral fludarabine
Intervention Description
Fludarabine 40mg/m2 po.d1-3; Adriamycin 50mg/m2 i.v.d1; Dexamethasone 20mg/d po.d1-5.
Primary Outcome Measure Information:
Title
side effects
Time Frame
1 months
Secondary Outcome Measure Information:
Title
PFS (progression free survival)
Time Frame
3 months
Title
complete remission(CR)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The diagnosis of peripheral T cell lymphoma must established by histological biopsy, and immunochemistry analysis and cytogenetic assessment should be done as well. The patients with peripheral T cell lymphoma (PTCL), PTCL-unspecified type(PTCL-u), angioimmunoblastic lymphoma (AILT) and non-skin type anaplastic large cell lymphoma (ALCL, ALK-). Aged 18~75. Good performance status, ECOG score≤2. Estimated survival span >3 months Previously untreated. At least 1 assessable disease (maximal diameter >1.0cm, the disease foci located within the irradiated area are excluded) evaluated by CT or MRI, PET is also permitted. Good compliance and inform consenting Fit for the following criteria: Absolute neutrophil count (ANC)≥1.5×109/L Platelet（PLT）≥80×109/L Total bilirubin (TBI) ≤upper normal limit (UNL) Serum creatine (Cr) ≤UNL Alanine aminotransferase (ALT) and Aspartate transaminase（AST）≤1.5 UNL Exclusion Criteria: Severe cardiac, renal or hepatic incompetence: serum direct bilirubin, indirect bilirubin, ALT, AST and Cr greater than 1.5 UNL; cardiac function greater than grade II. 28 days within the major surgical operation. Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded) Severe uncontrolled underlying diseases Pregnancy or lactation Autoimmune disease history Severe infection or metabolic diseases Known allergic to multiple agents, including sulphanilamide. Severe peptic ulceration or bleeding, contra-indicative for corticosteroids Lymphoma involving central nervous system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojian Liu, PhD
Phone
8613816983809
Email
xiaojian_liu068@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaonan Hong, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojian Liu, PhD
Phone
8613816983809
Ext
1107
Email
Xiaojian_liu068@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)

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